Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix K: IOM Staff Paper: Context and Glossary of Select Terms Associated with the Clinical Trials Enterprise
Appendix K: IOM Staff Paper: Context and Glossary of Select Terms Associated with the Clinical Trials Enterprise
Pages 225-232
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Clinical trials conducted without the goal of regulatory approval might test a drug or intervention in a diverse group of study participants, include a longer time frame for follow-up of study subjects, and address a broader set of questions.
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SOURCE: IOM, 2010b. Redesigning the Clinical Effectiveness Research Paradigm.
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: a broad term that encompasses the full spectrum of clinical trials and their applications. The CTE includes the processes, institutions, and individuals that eventually apply clinical trial findings to patient care.
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Today, the concept of continuous improvement in health care includes more than just measurements of quality and could also incorporate innovation and a strong scientific foundation to inform improvement efforts. Several workshop participants suggested that to pursue the goal of further integrating clinical research and practice, policy change or clarification be taken up that would expressly permit inclusion of routine evidence generation activities of health care organizations that pose no more than a minimal risk to patients under the concept of continuous improvement activities, which would have the effect of exempting these activities from the traditional regulatory frame work applied to experimental research activities (e.g., Common Rule, HIPAA)
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Also called a "virtual" clinical trial, this could result in faster clinical trials as the potentially eligible patient population includes anyone with internet access -- as opposed to the current model that relies on recruiting patients who live in close proximity to clinical trial sites. Trial sponsors could also realize lower clinical trial costs using this model because individual "brick and mortar" trial sites would not need to be set up across the country.
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. Satisfying GCP requirements provides assurance that the data and reported results of the clinical trial are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected (ICH, 1996)
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Protocols are required to be submitted to the relevant institutions and organizations that provide ethical and regulatory approval for clinical trials. Protocol design plays a crucial role in the success of a trial as it outlines exactly what the trial will entail, the eligibility criteria for those who can participate, and the frequency of the procedures and treatments that trial participants will be expected to receive over the course of the study.
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2008. Assessing the impact of protocol design change on clinical trial performance.
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Key Terms
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